Description

Linagliptin Impurity E CAS NO 1446263-38-2 is a specified impurity of the antidiabetic drug Linagliptin, used in analytical research and pharmaceutical development. This compound is critical for quality control and regulatory compliance, ensuring the safety and efficacy of the final drug product. It is primarily needed by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Linagliptin Impurity E in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine quality control testing to monitor batch-to-batch consistency and impurity levels.
• Stability Studies: Employed to track the formation and growth of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Used in synthetic chemistry research to study the formation pathways and chemical behavior of this impurity.

Basic Information

Product Name	Linagliptin Impurity E
CAS No.	1446263-38-2
Molecular Formula	C25H28N8O2
Molecular Weight	472.55 g/mol
Synonyms	8-[(3R)-3-Aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione; BI-1356 Impurity E; (R)-Odanacatib Impurity E (related compound); Tradjenta Impurity E; 1H-Purine-2,6-dione, 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-
EINECS	Contact for details

Quality Control

Our Linagliptin Impurity E is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with batch-specific data is provided, supporting compliance with ICH Q3A/B guidelines and cGMP principles.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.